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Would you like to apply your Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines for products in development.
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The Department is recruiting for current Office Services Coordinator (OSC) vacancies in our Aging and Disability Services, Behavioral Health and Crisis Services, and the Office of Community Affairs.
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Examples may include use of regulatory guides, industry codes, and standards, Federal and state emergency preparedness and incident response programs, and applicable FEMA or EPA regulations/guidance.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Electrical System Design: Evaluate and design electrical, avionics and related systems for Hughes' broadband internet connectivity product, ensuring those designs meet performance, safety, and regulatory requirements.
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The Montgomery County Department of Housing and Community Affairs (DHCA) is currently seeking to fill two Housing Code Inspector positions. Montgomery County Government is an equal opportunity employer, committed to workforce diversity.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Responsibilities include coordinating and analyzing samples using immunoassays (ELISA, Luminex, Meso Scale, etc) and cell assays (flow cytometry), maintenance of biobanks and inventories, developing assays, and reporting to cross-functional teams.
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Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses. Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents.
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Provide clinical documentation using malaria databases, NIH electronic medical records, and regulatory documentation of events post-vaccination. Must have experience with WHO and FDA regulatory authorities as it pertains to the conduction of human clinical trials.
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Assist in the preparation and review of bioanalytical data and reports suitable for regulatory submission. Background in molecular biology techniques such as cloning, site-directed mutagenesis, DNA and RNA isolation and purification, sequencing, RT-PCR, and qPCR.
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Collaborate with internal and external legal and policy specialists on various gaming related law and regulatory issues, including privacy, accessibility and digital safety matters associated with the video gaming industry.
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The Technical Expert is responsible for understanding the regulatory and policy landscape for genetic biocontrol approaches to control malaria and other vector-borne diseases; planning and implementing a portfolio of activities to provide technical information and advice on regulation and policy to stakeholders; and collaborating with partners to build regulatory and policy capacity, particularly through online and in-person trainings.
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You will facilitate collaboration with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
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Oversee the related expansion and optimization of global capabilities across manufacturing, quality, process development, analytical development, supply chain, and regulatory affairs. Collaborate closely with the Chief Operating Officer and their leadership team to effectively manage operations concerning the Novavax COVID vaccine, the company's proprietary MATRIX adjuvant product, and the global launch of new COVID variant vaccines, alongside innovative products like the Flu-COVID Combination vaccine (CIC.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Jobget in Germantown, MD
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